Weight Management in Nonalcoholic Steatohepatitis

NCT00266019 | Completed Phase 2

• 1 other identifier: DK67363 (completed)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Nonalcoholic steatohepatitis (NASH) is one of the most common chronic liver diseases. The cause of NASH is not completely understood and currently there is no effective treatment for this disease. An effective approach to treatment is needed since without treatment this disease may progress to fibrosis and cirrhosis. Obesity is one of the most important risk factors for NASH and weight reduction is generally recommended as an initial step in its management. However, there are very limited data on the efficacy of weight reduction as a treatment for NASH. Data from uncontrolled trials using poorly defined primary outcome measures and patient populations and nonstandardized weight loss interventions suggest that modest weight loss may improve fatty liver disease. The objective of this project is to conduct a randomized controlled trial of weight reduction in the management of NASH using a combination of diet, exercise, and behavior modification.

Conditions

Fatty Liver

Keywords

nonalcoholic steatohepatitis; nonalcoholic fatty liver disease; Fatty liver; Cirrhosis; Obesity; Weight Reduction; Weight Management

Outcome Measures

Primary Outcomes (2)

• Liver histology score (NASH-Clinical Research Network [CRN] scoring system) at 48 weeks

• Weight reduction at 48 weeks

Secondary Outcomes (4)

• Insulin sensitivity at 48 weeks

• Liver function test at 48 weeks

• Inflammatory markers and adipokine levels at 48 weeks

• Quality of life at 48 weeks

Interventions

Weight Management (diet, exercise, and behavior modification) BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of chronic steatohepatitis on liver biopsy.
• Elevated alanine or aspartate aminotransferase values (ALT \> 41 or AST \> 34) within 3 months of enrollment
• Absence of another form of liver disease
• Body mass index between 25-50 kg/m2.
• At least 18 years of age
• Absence of significant alcohol consumption (more than one standard drink per day).
• Able to walk 2 blocks or a quarter of a mile without stopping
• Willing to complete a two-week run-in period with successful completion of self-monitoring records.

You may not qualify if:

• \< 18 years of age
• Significant alcohol consumption (\> 1 standard drink per day)
• Contraindications to obtaining a liver biopsy
• Unable to walk 2 blocks or a quarter of a mile without stopping
• Currently pregnant or pregnant in the previous six months
• Currently engaged in an active weight-loss program or taking weight-loss medication
• Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol for 12 months, including illness likely to be terminal within 2 years, plans to move, substance abuse, or other significant psychiatric problems

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (5)

• Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

  PMID: 11832527 BACKGROUND

• Ludwig J, Viggiano TR, McGill DB, Oh BJ. Nonalcoholic steatohepatitis: Mayo Clinic experiences with a hitherto unnamed disease. Mayo Clin Proc. 1980 Jul;55(7):434-8.

  PMID: 7382552 BACKGROUND

• Bacon BR, Farahvash MJ, Janney CG, Neuschwander-Tetri BA. Nonalcoholic steatohepatitis: an expanded clinical entity. Gastroenterology. 1994 Oct;107(4):1103-9. doi: 10.1016/0016-5085(94)90235-6.

  PMID: 7523217 BACKGROUND

• Kleiner DE, Brunt EM, Van Natta M, Behling C, Contos MJ, Cummings OW, Ferrell LD, Liu YC, Torbenson MS, Unalp-Arida A, Yeh M, McCullough AJ, Sanyal AJ; Nonalcoholic Steatohepatitis Clinical Research Network. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology. 2005 Jun;41(6):1313-21. doi: 10.1002/hep.20701.

  PMID: 15915461 BACKGROUND

• Ueno T, Sugawara H, Sujaku K, Hashimoto O, Tsuji R, Tamaki S, Torimura T, Inuzuka S, Sata M, Tanikawa K. Therapeutic effects of restricted diet and exercise in obese patients with fatty liver. J Hepatol. 1997 Jul;27(1):103-7. doi: 10.1016/s0168-8278(97)80287-5.

  PMID: 9252081 BACKGROUND

MeSH Terms

Conditions

Fatty Liver; Non-alcoholic Fatty Liver Disease; Fibrosis; Obesity; Weight Loss

Interventions

Diet; Exercise; Behavior Therapy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kittichai Promrat, M.D.

  Rhode Island Hospital/Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 14, 2005
• First Posted: December 15, 2005
• Study Start: January 1, 2005
• Study Completion: December 1, 2007
• Last Updated: January 13, 2010

Record last verified: 2010-01

Locations

US (1)